Roche Inform II User manual

Category
Measuring, testing & control
Type
User manual

This manual is also suitable for

Accu-Chek
®
Inform II
BLOOD GLUCOSE MONITORING SYSTEM
Operator’s Manual
2
Revision History
Manual version Revision date Changes
Version 1.0 2008-01 New document
Version 2.0 2009-08 Update, new SW version 02.00
Version 3.0 2010-09 Update, new SW version 03.00
Version 4.0 2012-11 Update, new SW version 03.04 (OTS, OTE), revision
Cleaning/Disinfection section; misc. editorial revisions
Version 5.0 2013-09 Transition to new meter hardware: 2D barcode scan-
ner, modifications to wireless LAN option (separate
insertable RF card replaced by integrated WLAN com-
ponent); new battery pack. Update to SW 04.00; misc.
editorial revisions.
0 4807839001 (05) 2013-09 EN
Operator’s Manual
Version 5.0
A
A
CCU-
CCU-C
HEK
HEK
®
Inform II System
4
© 2008-2013, Roche Diagnostics. All rights reserved.
The contents of this document, including all graphics, are the property of Roche Diagnostics. No part of this
document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any
purpose, without the express written permission of Roche Diagnostics. Roche Diagnostics has made every
reasonable effort to ensure that all the information contained in this manual is correct at the time of printing.
However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of
ongoing product development.
Please send questions or comments about this manual to your local Roche representative.
ACCU-CHEK, ACCU-CHEK INFORM, ACCU-CHEK PERFORMA and COBAS are trademarks of Roche.
All other trademarks are the property of their respective owners.
The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance.
5
On the packaging, on the identification plate of the meter, the battery pack, the base unit, or the code key
reader you may encounter the following symbols, shown here with their meaning:
On meters with WLAN capability:
For other WLAN certifications, see label on bottom of battery compartment and list included in meter kit.
Caution, consult accompanying documents. Refer to safety-related notes in the instructions
for use accompanying this product.
Temperature limitation (Store at)
Manufacturer
Catalog number
In vitro diagnostic medical device
This product fulfills the requirements of the European Directives 98/79/EC on in vitro
diagnostic medical devices and 1999/5/EC on radio and telecommunications terminal
equipment (R&TTE).
The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in accordance
with UL 61010-1 and CAN/CSA-C22.2 No. 61010-1).
Power supply connection
This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada.
The compliance mark indicates that the product complies with the applicable standard and
establishes a traceable link between the equipment and the manufacturer, importer or their
agent responsible for compliance and for placing it on the Australian and New Zealand
market.
IVD
7.5V 1.7A
6
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7
1 Introduction 13
1.1 Before you start......................................................................................................................................... 13
Intended use ...................................................................................................................................... 13
Important information regarding use ....................................................................................... 13
If you need help................................................................................................................................ 14
Note on the use of “base unit” in this manual...................................................................... 14
Note on illustrations in this manual .......................................................................................... 14
What can the system do for you? .............................................................................................. 15
1.2 Important safety instructions and additional information......................................................... 16
Important information regarding safety................................................................................... 17
Disposal of the system ................................................................................................................... 18
Product safety.................................................................................................................................... 19
General care....................................................................................................................................... 19
Accessory box ................................................................................................................................... 19
Meter .................................................................................................................................................... 19
Automatic power-off....................................................................................................................... 19
Battery Pack ....................................................................................................................................... 20
Touchscreen....................................................................................................................................... 21
Electrostatic discharge (ESD)...................................................................................................... 21
Local Area Network: protection from unauthorized access ............................................ 22
Wired network connection ........................................................................................................... 22
Wireless connectivity ...................................................................................................................... 23
Radiofrequency radiation exposure information.................................................................. 24
1.3 System components................................................................................................................................ 27
1.4 Overview of the meter ............................................................................................................................ 28
1.5 Overview of the code key reader ....................................................................................................... 30
1.6 Overview of the base unit ..................................................................................................................... 31
1.7 Overview of the Accu-Chek Inform II Base Unit Hub................................................................. 32
1.8 Overview of the accessory box ........................................................................................................... 33
1.9 Reagents and consumables................................................................................................................. 33
1.10 Instructions for initial setup.................................................................................................................. 34
2 Powering Up and Entering an Operator ID 35
2.1 Powering up the meter .......................................................................................................................... 35
Adjusting the display ...................................................................................................................... 36
Enabling/disabling wireless connectivity ................................................................................ 36
Closing startup.................................................................................................................................. 37
2.2 Entering the operator ID........................................................................................................................ 38
Entering an operator ID with barcode scanner .................................................................... 39
Entering the operator ID manually ............................................................................................ 40
Entering a password ....................................................................................................................... 40
8
3 Patient Glucose Testing 41
3.1 Information regarding blood glucose testing ................................................................................ 41
Preparing to test ............................................................................................................................... 41
3.2 Performing a patient glucose test...................................................................................................... 42
Overview of test procedure .......................................................................................................... 42
Entering or selecting the patient ID .......................................................................................... 43
Entering the patient ID manually................................................................................................ 45
Selecting the patient ID from a list............................................................................................ 45
Entering a patient ID with barcode scanner .......................................................................... 46
Confirming or selecting the test strip lot................................................................................. 47
Inserting test strips .......................................................................................................................... 48
Obtaining a blood sample............................................................................................................. 49
Applying a blood sample............................................................................................................... 50
Results screen ................................................................................................................................... 51
Adding comments............................................................................................................................ 54
4 Glucose Control Testing 57
4.1 Information regarding glucose control tests.................................................................................. 57
Glucose control testing intervals................................................................................................ 58
Information stored during glucose control testing.............................................................. 59
Control solutions............................................................................................................................... 60
Preparing to run a glucose control test ................................................................................... 60
4.2 Performing glucose control tests ....................................................................................................... 61
Overview of test procedure .......................................................................................................... 61
Starting a glucose control test .................................................................................................... 62
Confirming or selecting the lot number for control solutions ......................................... 63
Confirming or selecting the test strip lot................................................................................. 64
Inserting test strips .......................................................................................................................... 65
Applying the control solution....................................................................................................... 66
Results screen ................................................................................................................................... 67
Performing a STAT test .................................................................................................................. 68
5 Review Results 69
5.1 Displaying test results from the memory ........................................................................................ 69
Information stored in data records for test results.............................................................. 69
List of results stored in the memory.......................................................................................... 70
6 Storing Test Strip, Control Solution, and Linearity Solution
Information in the Meter 73
6.1 Storing information about test strips ................................................................................................ 73
Transferring code key information to the meter................................................................... 74
Editing test strip data...................................................................................................................... 77
6.2 Storing control solution information ................................................................................................. 80
Entering the lot number of the control solution ................................................................... 80
Selecting a stored lot number as the current lot number................................................. 83
6.3 Storing linearity test information ........................................................................................................ 85
Entering the lot number of the linearity test .......................................................................... 85
Selecting a stored lot number as the current lot number................................................. 87
9
7 Linearity Testing 89
7.1 Information regarding linearity tests................................................................................................. 89
Linearity testing intervals .............................................................................................................. 90
Information stored during linearity testing............................................................................. 90
Linearity test kit ................................................................................................................................ 91
Preparing to run a linearity test .................................................................................................. 91
7.2 Performing a linearity test..................................................................................................................... 92
Overview of test procedure .......................................................................................................... 92
Starting a linearity test ................................................................................................................... 92
Confirming or selecting the lot number for linearity test kits.......................................... 93
Confirming or selecting the test strip lot................................................................................. 93
Inserting test strips.......................................................................................................................... 94
Applying a linearity test sample ................................................................................................. 95
Results screen ................................................................................................................................... 96
8 Proficiency Testing 97
8.1 Information regarding proficiency tests .......................................................................................... 97
Information stored during proficiency testing....................................................................... 98
Preparing a proficiency test ......................................................................................................... 98
8.2 Performing a proficiency test............................................................................................................... 99
Overview of test procedure .......................................................................................................... 99
Starting a proficiency test............................................................................................................. 99
Entering the proficiency sample ID........................................................................................ 100
Confirming or selecting the test strip lot.............................................................................. 100
Inserting test strips....................................................................................................................... 101
Applying a proficiency sample................................................................................................. 102
Results screen ................................................................................................................................ 103
9 Initial Startup 105
9.1 Connecting the base unit ................................................................................................................. 105
9.2 Installing or replacing the battery pack ...................................................................................... 106
Removing the battery pack ....................................................................................................... 107
Installing the battery pack ......................................................................................................... 108
9.3 Docking the meter................................................................................................................................ 110
9.4 Initial setup on the meter................................................................................................................... 112
Menu overview............................................................................................................................... 113
9.5 Opening the Setup Menu .................................................................................................................. 116
9.6 Date and time format........................................................................................................................... 117
9.7 Display options and optional tests ................................................................................................. 118
9.8 Options for test strips .......................................................................................................................... 119
9.9 Options for glucose control tests.................................................................................................... 121
9.10 Value ranges (normal, critical, reportable).................................................................................. 123
9.11 Options for Operator ID Entry........................................................................................................... 124
9.12 Patient ID options.................................................................................................................................. 125
9.13 Creating a setup password................................................................................................................ 126
9.14 Setting the date and time................................................................................................................... 127
9.15 Beeper options....................................................................................................................................... 128
10
10 Maintenance and Care 129
10.1 Conditions for storage and shipping ............................................................................................. 129
General operating conditions ................................................................................................... 129
Storage .............................................................................................................................................. 130
10.2 Cleaning/disinfecting the Accu-Chek Inform II system.......................................................... 130
Acceptable cleaning/disinfecting agents............................................................................. 131
Cleaning/disinfecting the meter .............................................................................................. 132
How to clean/disinfect ................................................................................................................ 134
Cleaning the barcode scanner window................................................................................ 136
Cleaning/disinfecting the base unit ....................................................................................... 136
Cleaning/disinfecting the accessory box ............................................................................. 137
Cleaning the code key reader .................................................................................................. 138
Cleaning the Accu-Chek Inform II Base Unit Hub............................................................ 138
10.3 Logging maintenance activities....................................................................................................... 139
10.4 Diagnostics view.................................................................................................................................... 140
10.5 Unlocking a Download Lockout ...................................................................................................... 142
10.6 Deleting patient data ........................................................................................................................... 144
11 Troubleshooting 145
Errors and unusual behavior without error messages .................................................... 145
Pop-up messages.......................................................................................................................... 149
Meter reset ...................................................................................................................................... 151
12 General Product Information 153
12.1 Technical data ....................................................................................................................................... 153
12.2 Further Information............................................................................................................................... 156
Ordering ........................................................................................................................................... 156
Accu-Chek Inform II Operator’s Manual and Quick Reference Guide..................... 157
Reagents and Solutions.............................................................................................................. 157
Information about software licenses...................................................................................... 158
Contact Roche................................................................................................................................ 159
A Appendix 161
A.1 Table of configuration options ......................................................................................................... 161
A.2 Example of barcode symbologies ................................................................................................... 173
B Appendix 175
B.1 Option: Wireless network (WLAN).................................................................................................. 175
Preliminary note............................................................................................................................. 175
Background ..................................................................................................................................... 175
Technical implementation.......................................................................................................... 176
RF specific functionalities and effective performance claims...................................... 178
11
C Supplement for Other Test Entry 181
C.1 Before you start...................................................................................................................................... 181
Description ...................................................................................................................................... 181
C.2 Overview of Other Test Entry (OTE) ............................................................................................... 182
Introduction..................................................................................................................................... 182
C.3 Recording Other Patient Tests ......................................................................................................... 185
C.4 Recording Other Control Tests ........................................................................................................ 192
Introduction..................................................................................................................................... 192
Other Control Testing Intervals................................................................................................ 192
Stored Control Information........................................................................................................ 192
Warning messages ....................................................................................................................... 198
C.5 Reviewing Other Test Results........................................................................................................... 199
C.6 Other Test Entry Configuration Options ....................................................................................... 202
D Supplement for Observed Test Sequence 203
Observed Test Sequence (OTS)............................................................................................... 203
Using the OTS function............................................................................................................... 204
Index 207
12
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Introduction • 1
13
1 Introduction
1.1 Before you start
Intended use The Accu-Chek
®
Inform II system is intended for in vitro
diagnostic use in the quantitative determination of blood
glucose levels in venous, capillary, arterial, and neonatal
whole blood samples for monitoring blood glucose. The
system is indicated for use by healthcare professionals.
For healthcare professionals, the system is a bedside unit
that can help you provide quality patient care by measur-
ing blood glucose and by automating the record keeping
associated with blood glucose and glucose control tests.
Important information regarding
use
Read this operator's manual, as well as the package
inserts for all relevant consumables, before using the
system for the first test.
You must configure the Accu-Chek Inform II system
according to your needs before initial use. You can con-
figure the system either directly on the meter or by using
a suitable data management system. Refer to Chapter 9
“Initial setup on the meter” for on-meter configuration.
Refer to Appendix A for configuration via a data manage-
ment system.
Be sure to read the “Important safety instructions and
additional information” section in this chapter before
operating the system.
1 • Introduction
14
If you need help Information about using the system, the screen menus and
performing a test can be found in this operator's manual.
Error messages that appear on screen include informa-
tion or instructions on how to correct the error.
For all questions about the Accu-Chek Inform II system
that are not answered in this manual, contact your Roche
representative (see Chapter 12). In order to expedite
troubleshooting, please have ready your Accu-Chek
Inform II meter, its serial number, this manual, and all
related consumables when you call. If you suspect a com-
munication error beyond the meter, also have your
Accu-Chek Inform II Base Unit serial number ready to
help assist our customer care group in troubleshooting.
Note on the use of “base unit” in
this manual
Note on illustrations in this
manual
Unless otherwise specified, the term “base unit” refers
to both the Accu-Chek Inform II Base Unit and the
Accu-Chek Inform II Base Unit Light.
Illustrations in this manual show two different kinds of
hands:
Hand without glove Hand with glove
A dashed arrow between screen illustrations indicates
that some screens have been skipped in these
illustrations.
Introduction • 1
15
What can the system do for you? The Accu-Chek Inform II system has the following
features and properties:
Perform patient blood glucose tests and glucose
control tests with control solution.
Automatically record all relevant data for the appli-
cation, which includes:
Time and date of test
IDs for operator, patient, and samples
Information about control solutions, test strips, and
linearity
Test results and comments
Record patient test results, quality control test
results and reagent information for certain off-
meter manual tests.
For purposes of quality assurance, information on
the following areas can be collected, stored, and
transferred:
Meters
Test strips
Glucose control solutions
Linearity solutions
Test results
1 • Introduction
16
1.2 Important safety instructions and additional information
This section explains how safety-related messages and
information related to the proper handling of the system
are presented in the Accu-Chek Inform II manual. Please
read these passages carefully.
The safety alert symbol alone (without a signal word) pro-
motes awareness to hazards which are generic or directs
the reader to related safety information.
WARNING
WARNING
Indicates a hazardous situation which, if not avoided,
could result in death or serious injury.
CAUTION
CAUTION
Indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury.
NOTICE
NOTICE
Indicates a hazardous situation which, if not avoided,
may result in damage to the system.
Important information that is not safety relevant is
presented against a colored background (without a
symbol). Here you will find additional information on
correct use of the meter or useful tips.
Introduction • 1
17
Important information regarding
safety
Operator qualification
Only trained healthcare professionals may operate the
Accu-Chek Inform II system. Operators must also have
received comprehensive instruction in the operation,
quality control, and care of the Accu-Chek Inform II
system.
WARNING
Protection against infection and blood-borne
pathogens
Healthcare professionals using the Accu-Chek Inform II
system to perform tests on more than one patient must
be aware that any object coming into contact with
human blood is a potential source of infection. Operators
need to adhere to Standard Precautions when handling
or using the Accu-Chek Inform II system. All parts of this
system should be considered potentially infectious and
are capable of transmitting blood-borne pathogens
between patients and healthcare professionals.
Use gloves. Wear a new pair of clean gloves for
testing each patient.
Wash hands thoroughly with soap and water
before putting on a new pair of gloves and per-
forming the next patient test.
Use an auto-disabling single-use lancing device
for each patient.
Dispose of used lancets in a sturdy sharps con-
tainer with lid.
Dispose of used test strips from patient and
proficiency tests according to your institution’s
infection control policy.
Follow all health and safety regulations in force
locally.
1 • Introduction
18
Disposal of the system
CAUTION
Allergy or injury caused by reagents and other
working solutions
Direct contact with reagents, detergents, cleaning/disin-
fection solutions, or other working solutions may cause
skin irritation or inflammation.
Always use protective gloves.
Observe the cautions given in the package inserts of
the reagents and cleaning/disinfection solutions.
If a reagent, control, linearity, or cleaning/disinfection
solution comes into contact with your skin, wash it off
immediately with water.
Follow all health and safety regulations in force
locally.
WARNING
Infection by a potentially biohazardous instrument
The Accu-Chek Inform II system or its components must
be treated as potentially biohazardous waste. Decontam-
ination (i.e., a combination of processes including clean-
ing, disinfection and/or sterilization) is required before
reuse, recycling, or disposal.
Dispose of the system or its components according to
the appropriate local regulations or you may return it to
Roche. For more information, contact your Roche
representative.
Introduction • 1
19
Product safety Observe the following information to ensure product
safety:
The system is suitable for continuous operation.
General care
Accessory box
Meter
Dispose of the meter in accordance with applicable
laws and regulations. See “Disposal of the system”
on page 18.
Automatic power-off
Unless otherwise configured, the system automati-
cally powers off after 5 minutes of inactivity (e.g., no
screen touches, strip insertions).
In measurement mode only: If you are performing a
test (patient, control, proficiency, or linearity), the
meter will power off after 10 minutes of inactivity
(no screen touches), independently of configured
automatic power-off time. If a result is already
present, the meter will emit three warning beeps
every minute after 5 minutes of inactivity and will
save the result before powering off after 10 minutes
of inactivity.
NOTICE
The system is not protected against the harmful ingress
of fluids (IP X0 rating according to IEC 60529).
NOTICE
Clean the system only with the solutions recommended.
Using other solutions may result in incorrect operation
and possible failure of the system. Make sure that the
meter and base unit are thoroughly dried after cleaning
and disinfecting.
NOTICE
Carry the accessory box carefully by the handle for easy
transport. Dropping or hitting the box may damage it.
1 • Introduction
20
Battery Pack The meter contains a rechargeable battery pack that
begins charging as soon as it is placed in an active base
unit (i.e., one connected to a power supply).
Observe the following general safety instructions for
handling batteries:
When storing or disposing of the battery pack, use
the manufacturer's original packaging.
Always power off the meter before removing the
battery pack.
When the Battery Low warning is displayed, the
meter must be returned as soon as possible to
the base unit for recharging.
The Battery Critically Low warning indicates that
the meter must be returned immediately to the
base unit for recharging.
NOTICE
Use only the specially designed battery pack provided by
Roche Diagnostics. Using any other type of battery may
damage the system.
Disposal of used batteries
Do not dispose of the batteries with normal domestic
waste. Dispose of used batteries in accordance with
applicable local regulations and directives and your
facility’s guidelines on the disposal of electronic waste
equipment.
Save or download data from the meter prior to replac-
ing the battery pack to prevent loss of data (see
Chapter 9).
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Roche Inform II User manual

Category
Measuring, testing & control
Type
User manual
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